A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors

Treatments: Drug: PF-06939999 in combination with docetaxel; Drug: PF-06939999 monotherapy; Drug: PF-06939999 dose escalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03854227

C3851001

Details and patient eligibility

About

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed locally advanced or metastatic NSCLC, urothelial carcinoma or HNSCC
• Progressed after at least 1 line of treatment and no more than 3 lines of treatment
• At least one measurable lesion as defined by RECIST version 1.1
• ECOG Performance Status 0 or 1
• Adequate Bone Marrow Function
• Adequate Renal Function
• Adequate Liver Function
• Resolved acute effects of any prior therapy

Exclusion criteria

• Known active uncontrolled or symptomatic CNS metastases.
• Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry.
• Active, uncontrolled infection, including COVID-19
• Known or suspected hypersensitivity to PF-06939999
• Inability to consume or absorb study drug

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 6 patient groups

Dose Escalation

Experimental group

Description:

Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis

Treatment:

Drug: PF-06939999 dose escalation

Non small cell lung cancer monotherapy

Experimental group

Description:

Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis

Treatment:

Drug: PF-06939999 monotherapy

Urothelial carcinoma

Experimental group

Description:

Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis

Treatment:

Drug: PF-06939999 monotherapy

Head and neck squamous cell carcinoma

Experimental group

Description:

Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis

Treatment:

Drug: PF-06939999 monotherapy

Non small cell lung cancer PF-06939999 plus docetaxel

Experimental group

Description:

Participants will receive PF-06939999 on a continuous basis in combination with docetaxel

Treatment:

Drug: PF-06939999 in combination with docetaxel

Non small cell lung cancer dose finding

Experimental group

Description:

Participants will receive PF-06939999 on a continuous basis at escalating doses in combination with docetaxel

Treatment:

Drug: PF-06939999 in combination with docetaxel